Generic Drug Makers’ Push Back Against Warning Requirements

In response to proposed regulations that would make generic drug makers responsible for providing complete and updated label warnings about potential health risks associated with medications they manufacture and sell, the generic manufacturers are pushing back and indicate that it would cause confusion and increased costs.

Generic drug manufactuers have released a new economic analysis (PDF) of the costs associated with forcing them to adequately warn consumers about drug side effects, which may also restore the ability for consumers to pursue failure to warn lawsuits against generic drug makers when they suffer injuries that may have been prevented had appropriate warnings been provided.

The pharmaceutical companies are pushing back against a proposed FDA rule that would close a loophole created by the Supreme Court, which has allowed generic drug makers to avoid responsibility for injuries caused by medications they sell, even if they are aware the drugs contain dangerous side effects that are not adequately disclosed to consumers and the medical community.

Currently regulations require that generic drugs contain the same warning label that is provided on the brand name version of the medication, even if the manufacturer knows or reasonably should know that serious health risks associated with the drugs are not disclosed by the brand name manufacturer. This has caused many older drugs to be sold for years after potentially life-threatening health problems are discovered, especially when brand name versions are no longer manufactured.

Generic drug makers have relied on this restriction on their ability to update warnings as a shield against product liability lawsuits filed by consumers who allege they suffered an injury due to their failure to warn about known side effects. Known as pre-emption, the Supreme Court upheld this defense in the controversial 2011 ruling of Pliva v. Mensing, in which a split court ruled 5-4 down ideological lines that state failure to warn lawsuits are preempted by the federal regulations that require generic drugs contain the same warnings.

The impact of this ruling has left consumers without a recourse for serious and often devastating injuries caused by medications with known side effects that are no disclosed by the drug makers. Consumers are unable to pursue damages against the brand name manufacturers since they did not use their product, and any failure to warn lawsuits against generic drug makers are now barred. This has resulted in the dismissal of hundreds of Reglan lawsuits, Accutane lawsuits, Fosamax lawsuits and other claims where the plaintiffs only used the generic equivalent.

The new proposed FDA regulations would allow generic drug makers to update label warnings and safety information for their drugs, but the industry says such a move would be a mistake. According to a press release issued by the Generic Pharmaceutical Association, the industry representatives have indicated that holding pharmaceutical manufacturers responsible for updating warnings about known risks “would be nothing short of catastrophic.”

The Generic Pharmaceutical Association had a consulting form known as Matrix Global Advisors conduct an analysis of the cost of the new rule, which claims that it would add $4 billion to the cost of national healthcare. The association claims that they would be forced to make consumers pay more for their drugs if they were made liable for providing adequate drug side effect warning. They also claim the rule would lead to multiple drug labels for the same drugs, causing confusion among consumers. The generic drug makers indicate that another solution, one that does not require them to be held liable for warning patients about the side effects of their drugs, would be more sensible.

However, the FDA rejected those arguments in its proposed rulemaking. While generic companies claim the rule would allow them to change the labels without FDA approval, the FDA says that its new rules would include FDA review and approval of those label changes.

The position taken by the generic drug makers also does not account for the huge costs associated with the injuries caused by generic drugs, which may be avoided if proper warnings are provided. However, the generic drug makers prefer to continue generating profits from their medications without being responsible for the safety of consumers.

In August 2011, the prominent consumer advocacy group Public Citizen filed a petition with the FDA calling for the agency to amend the federal regulations that limit generic drug makers’ ability to update warning labels. The group indicated that the outdated regulations prevent consumers from learning about many known risks associated with generic drugs and has become a shield for pharmaceutical companies against product liability lawsuits.